StrokeVIVRANTNCT02507466
Very Intensive Variable Repetitive AmbulatioN Training
A study testing exercise in people with Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The overall objective of this subproject is to evaluate the individual and paired contributions of intensity and variability of stepping training on lower extremity (LE) function, health and community participation in patients with chronic hemiparesis post-stroke. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Stroke
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- history unilateral stroke > 6 months duration
- walks without physical assistance at speeds < 1.0 m/s
Who cannot join
- no other cardiopulmonary, metabolic, neurological orthopedic injury that may contribute to walking outcomes
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Institute of Chicago
Chicago, Illinois, 60611
About this study
The overall objective of this subproject is to evaluate the individual and paired contributions of intensity and variability of stepping training on lower extremity (LE) function, health and community participation in patients with chronic hemiparesis post-stroke.
Read the detailed description
The overall objective of this subproject is to evaluate the individual and paired contributions of intensity and variability of stepping training on lower extremity (LE) function, health and community participation in patients with chronic hemiparesis post-stroke. Using a RCT design/Intervention Efficacy paradigm, Aim 1 will investigate the independent and combined (paired) contributions of intensity and variability of stepping training on locomotor function, with secondary measures of health and community mobility. For Aim 2, we will evaluate the independent and combined effects of intensity and variability of stepping training on non-walking LE tasks. In Aim 3, we will evaluate the cost effectiveness of providing these interventions to accelerate motor recovery and health. Our central hypothesis is that results of this study will provide a theoretical foundation for implementation of physical therapy interventions which can facilitate short-term gains in locomotor function, and contribute to long-term improvements in health, function and participation through increased community mobility.
- Conditions
- Stroke
- Being tested
- exercise
- Keywords
- locomotion
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
Variable conditions of stepping practice
| Study group | Role | What they receive |
|---|---|---|
| Variable high-intensity Training | Experimental | high intensity variable stepping exercise on a treadmill and overground Receives: Behavioral: exercise |
| Variable low-intensity training | Active comparator | low intensity variable stepping exercise on a treadmill and overground Receives: Behavioral: exercise |
| Constant High Intensity Training | Active comparator | high intensity constant (forward) stepping exercise on a treadmill and overground Receives: Behavioral: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak walking speed
fastest comfortable walking speed overground
Measured: At baseline, following 8 weeks of training and a 2 month follow-up
Secondary outcomes (2)
Change in Functional Gait Assessment
dynamic balance activities
Measured: At baseline, following 8 weeks of training and a 2 month follow-up
Change in 5X sit-to-stand transfer time
non-walking functional mobility task
Measured: At baseline, following 8 weeks of training and a 2 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 arm RCT - high intensity variable, high intensity forward, low intensity variable
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas G Hornby, Shirley Ryan AbilityLab
- Investigators
- Thomas Hornby, PT, PhD, Principal investigator, RIC/NU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507466
- Sponsor's protocol ID
- STU00103739
- Acronym
- VIVRANT
- Status last verified
- Jan 2020
- First submitted
- 21 Jul 2015
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2.
PubMed 34695300Hornby TG, Henderson CE, Holleran CL, Lovell L, Roth EJ, Jang JH. Stepwise Regression and Latent Profile Analyses of Locomotor Outcomes Poststroke. Stroke. 2020 Oct;51(10):3074-3082. doi: 10.1161/STROKEAHA.120.031065. Epub 2020 Sep 4.
PubMed 32883192Ardestani MM, Henderson CE, Mahtani G, Connolly M, Hornby TG. Locomotor Kinematics and Kinetics Following High-Intensity Stepping Training in Variable Contexts Poststroke. Neurorehabil Neural Repair. 2020 Jul;34(7):652-660. doi: 10.1177/1545968320929675. Epub 2020 Jun 6.
PubMed 32507027Hornby TG, Henderson CE, Plawecki A, Lucas E, Lotter J, Holthus M, Brazg G, Fahey M, Woodward J, Ardestani M, Roth EJ. Contributions of Stepping Intensity and Variability to Mobility in Individuals Poststroke. Stroke. 2019 Sep;50(9):2492-2499. doi: 10.1161/STROKEAHA.119.026254. Epub 2019 Aug 22.
PubMed 31434543
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Very Intensive Variable Repetitive AmbulatioN Training
- ClinicalTrials.gov ID
- NCT02507466
- Acronym / sponsor ID
- VIVRANT / STU00103739
- Conditions
- Stroke
- Keywords
- locomotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 24 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this subproject is to evaluate the individual and paired contributions of intensity and variability of stepping training on lower extremity (LE) function, health and community participation in patients with chronic hemiparesis post-stroke.
Detailed description
The overall objective of this subproject is to evaluate the individual and paired contributions of intensity and variability of stepping training on lower extremity (LE) function, health and community participation in patients with chronic hemiparesis post-stroke. Using a RCT design/Intervention Efficacy paradigm, Aim 1 will investigate the independent and combined (paired) contributions of intensity and variability of stepping training on locomotor function, with secondary measures of health and community mobility. For Aim 2, we will evaluate the independent and combined effects of intensity and variability of stepping training on non-walking LE tasks. In Aim 3, we will evaluate the cost effectiveness of providing these interventions to accelerate motor recovery and health. Our central hypothesis is that results of this study will provide a theoretical foundation for implementation of physical therapy interventions which can facilitate short-term gains in locomotor function, and contribute to long-term improvements in health, function and participation through increased community mobility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 3 arm RCT - high intensity variable, high intensity forward, low intensity variable
| Arm | Type | Receives |
|---|---|---|
| Variable high-intensity Training | Experimental | Behavioral: exercisehigh intensity variable stepping exercise on a treadmill and overground |
| Variable low-intensity training | Active comparator | Behavioral: exerciselow intensity variable stepping exercise on a treadmill and overground |
| Constant High Intensity Training | Active comparator | Behavioral: exercisehigh intensity constant (forward) stepping exercise on a treadmill and overground |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- history unilateral stroke > 6 months duration
- walks without physical assistance at speeds < 1.0 m/s
Key exclusion criteria (1 listed)
- no other cardiopulmonary, metabolic, neurological orthopedic injury that may contribute to walking outcomes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exerciseVariable conditions of stepping practice | Behavioural | Constant High Intensity Training, Variable high-intensity Training, Variable low-intensity training |
Primary outcome
Change in peak walking speed
Time frame: At baseline, following 8 weeks of training and a 2 month follow-up
fastest comfortable walking speed overground
2 secondary outcomes
Change in Functional Gait Assessment
Time frame: At baseline, following 8 weeks of training and a 2 month follow-up
Change in 5X sit-to-stand transfer time
Time frame: At baseline, following 8 weeks of training and a 2 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
- Derived from this study: PubMed 34695300Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2.
- Derived from this study: PubMed 32883192Hornby TG, Henderson CE, Holleran CL, Lovell L, Roth EJ, Jang JH. Stepwise Regression and Latent Profile Analyses of Locomotor Outcomes Poststroke. Stroke. 2020 Oct;51(10):3074-3082. doi: 10.1161/STROKEAHA.120.031065. Epub 2020 Sep 4.
- Derived from this study: PubMed 32507027Ardestani MM, Henderson CE, Mahtani G, Connolly M, Hornby TG. Locomotor Kinematics and Kinetics Following High-Intensity Stepping Training in Variable Contexts Poststroke. Neurorehabil Neural Repair. 2020 Jul;34(7):652-660. doi: 10.1177/1545968320929675. Epub 2020 Jun 6.
- Derived from this study: PubMed 31434543Hornby TG, Henderson CE, Plawecki A, Lucas E, Lotter J, Holthus M, Brazg G, Fahey M, Woodward J, Ardestani M, Roth EJ. Contributions of Stepping Intensity and Variability to Mobility in Individuals Poststroke. Stroke. 2019 Sep;50(9):2492-2499. doi: 10.1161/STROKEAHA.119.026254. Epub 2019 Aug 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Hornby, PT, PhD principal investigator
RIC/NU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak walking speed (time frame: At baseline, following 8 weeks of training and a 2 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02507466, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2020.